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Home > "D" Clinical Trials Conditions > Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer

Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer



Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer

For Condition: stage 4 breast cancer,stage 3A breast cancer,stage 3B breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.
Details: OBJECTIVES: - Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel. - Compare the toxicities and pharmacoeconomics of these four regimens in these patients. - Compare the quality of life of patients treated with these four regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no). Patients are randomized to one of four treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour on day 1. - Arm II: Patients receive paclitaxel IV over 3 hours on day 1. - Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. - Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 8 weeks. PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven unresectable locally advanced or metastatic breast cancer - Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines - At least one bidimensionally measurable lesion - No brain metastasis - No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease - Hormone receptor status: - Known hormone receptor status PATIENT CHARACTERISTICS: Age: - 18 to 75 Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - AST and ALT no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - Bilirubin normal Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled angina or arrhythmia - No myocardial infarction within the past 6 months - No New York Heart Association class III or IV heart disease Other: - No sensitive neuropathy worse than grade 2 - No other significant, uncontrolled medical or psychiatric condition - No serious active infection - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior specific antitumoral immunotherapy Chemotherapy: - See Disease Characteristics - No prior taxanes - At least 4 weeks since other prior specific antitumoral chemotherapy Endocrine therapy: - At least 4 weeks since prior specific antitumoral hormonal therapy Radiotherapy: - At least 4 weeks since prior specific antitumoral radiotherapy Surgery: - Not specified Other: - No other concurrent experimental medication
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JosephGligorov,  Study Chair,  Hopital Tenon

Clinique Fleming
Tours,  ,  37000
France
 

Clinique Hartmann
Neuilly-sur-Seine,  ,  92200
France
 

American Hospital of Paris
Neuilly-sur-Seine,  ,  F-92202
France
 

Hopital Saint Joseph
Marseille,  ,  13008
France
 

Polyclinique De Courlancy
Reims,  ,  F-51100
France
 

Hopital Drevon
Dijon,  ,  21000
France
 

Centre Hospitalier Laennec
Creil,  ,  60109
France
 

CH Meulan
Meulan,  ,  78250
France
 

Centre D'Oncologie Du Pays-Basque
Bayonne,  ,  F-64100
France
 

Clinique Geoffroy St. Hillaire
Paris,  ,  75005
France
 

Hopital Louis Mourier
Colombes,  , 
France
 

C.H.G. Beauvais
Beauvais,  ,  60021
France
 

Centre Hospitalier de Mulhouse
Mulhouse,  ,  68051
France
 

Hopital Intercommunal De Creteil
Creteil,  ,  94010
France
 

Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette,  ,  L-4005
Luxembourg
 

Centre Jean Perrin
Clermont-Ferrand,  ,  63011
France
 

Hopital Saint Antoine
Paris,  ,  75571
France
 

Centre Hospitalier Victor Dupouy
Argenteuil,  ,  95107
France
 

Clinique de l'Orangerie
Strasbourg,  ,  67010
France
 

Hopital Notre-Dame de Bon Secours
Metz,  ,  57038
France
 

Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil-les-Meaux,  ,  77100
France
 

Centre du Rouget
Sarcelles,  ,  95250
France
 

Clinique Pasteur
Toulouse,  ,  31076
France
 

Hotel Dieu de Paris
Paris,  ,  75181
France
 

Centre Hospitalier d'Antibes
Antibes,  ,  06606
France
 

Clinique Ste - Marie
Pontoise,  ,  95301
France
 

Intercommunal Hospital
Montfermeil,  ,  93370
France
 

Hopital Tenon
Paris,  ,  75970
France
 

Hopital Desgenettes - Service de Medecine Interne
Lyon,  ,  69998
France
 

Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
Gien,  ,  45500
France
 

Centre Jean Bernard
Le Mans,  ,  72000
France
 

Institut Sainte Catherine
Avignon,  ,  84082
France
 

Clinique Floreal
Bagnolet,  ,  28630
France
 

C.H. Senlis
Senlis,  ,  60309
France
 

Hopital Fontenoy
Chartres,  ,  28018
France
 


Additional Information:
Study ID Numbers:
  CDR0000068134;  FRE-GERCOR-TAXMAX-SOO-1,EU-20029
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006120

Other Stage 4 Breast Cancer Studies:
1. Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

2. Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer

3. Letrozole With or Without CCI-779 in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

4. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer

5. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer

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